Manager, Regulatory Affairs - Shockwave Medical

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Manager, Regulatory Affairs – Shockwave Medical to join our team. The position is FULLY REMOTE and can sit anywhere in the US.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Regulatory Affairs Manager works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI).  The Regulatory Affairs Manager combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements.  With guidance from responsible Regulatory Affairs Management, functions independently as a decision-maker on regulatory issues, assures that submission/registration/renewal deadlines are met, and supports new product development.  Effectively communicates, prepares, and negotiates both internally and externally with various regulatory agencies. The Regulatory Affairs Manager properly interprets and applies regulatory requirements and is recognized as a discipline expert and resource in Regulatory Affairs.

Essential Job Functions

• Collaboratively interface with a variety of levels on significant matters, often requiring the coordination of activity across organizational units

• Manage, mentor, and develop direct reports to meet individual and company goals and objectives

• Develop and follow regulatory policies, processes and SOPs and may train key personnel on them

• Develop regulatory strategies and update strategy based upon regulatory changes

• Determine submission and approval requirements in assigned geographies

• Provide strategic input and technical guidance on regulatory requirements to product development and operations teams

• Work with product development, quality and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, REACH, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents)

• Review and approve R&D, quality, preclinical and clinical documentation for submission filing

• In collaboration with cross-functional team members, compile, prepare, review and submit regulatory submissions to authorities in and outside the US (e.g., EU, Canada, Australia, Japan, etc.)

• Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals

• Communicate application progress to internal stakeholders

• Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies. 

• Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements

• Direct the process for preparation and maintaining annual licenses, registrations/listings for assigned geographies

• Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation

• Provide regulatory input for product recalls and recall communications

• In collaboration with Regulatory Management,